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Hansoh initiates the trial of anti-B7H4 ADC plus anti-PD-L1 or anti-VEGF mAbs in solid tumors

Hansoh conducted a new clinical study to evaluate the efficacy of anti-B7H4 ADC in combination with anti-PD-L1 or anti-VEGF mAbs for treating solid tumors. This marks the 3rd clinical trial for HS-20089 in China. HS-20089 is a novel B7-H4 targeted ADC with a TOPOi payload (DAR=6) , developed by Hansoh and licensed to GSK with an $85 million upfront payment. Factors controlling B7-H4 and B7-H4 receptor expression The clinical study This study contains four combination therapy cohorts, each consisting of a dose exploration part and a dose expansion part. The combination includes Adebrelimab, an anti-PD-L1 monoclonal antibody, either with or without platinum, or Bevacizumab with or without platinum. Adebrelimab was an anti-PD-L1 monoclonal antibody discovered and launched by Hengrui in China as their second anti-PD-(L)1 therapy. The clinical trial identified as NCT06336707 is expected to enroll a total of 1,048 participants, while the trial registered in China (CTR20241023) showed an e

China's CDE accepted the IND application for Phase 2 trial of TRS005

  Teruisi announced that the Investigational New Drug (IND) application for the phase 2 trial of TRS005 has been accepted by China's Center for Drug Evaluation (CDE). TRS005 is an antibody-drug conjugate (ADC) targeting CD20, utilizing anti-CD20 antibodies conjugated with MMAE (monomethyl auristatin E) for a more targeted therapeutic approach, with a drug-antibody ratio of 4:2. They have now progressed the candidate to a potential registrational study. TRS005  The single-arm Phase 2 study is aimed at rrDLBCL, with an estimated enrollment of 120-140 participants. The completion of the study may take two years, followed by an additional year for the Biologics License Application (BLA) review. Phase 1 Study Review Meeting The results of the Phase 1 trial in pts with rrNHL after receiving at least 2 standard treatment regimens, initiated in November 2018, were reported in 2022: " From Aug 24, 2020 to Apr 29, 2022, 40 pts received treatment, including 14 pts in dose-escalation pha

Beigene Initiates Phase 1 Trial of BG-C9074 Monotherapy and in Combo with Tislelizumab

 Beigene has registered a Phase 1 clinical trial ( NCT06233942 ) of BG-C9074, an anti-B7H4 antibody-drug conjugate (ADC), as monotherapy or in combination with tislelizumab: enrolling approximately 150 patients with pretreated solid tumors. The study (still no IND application submission in China yet) is estimated to start in May 2024, which is in line with the target for 2024 H1. BG-C9074 According to the Beigene slide deck, BG-C9074, a novel B7-H4-targeted ADC with a drug-to-antibody ratio (DAR) of 6 , is designed to balance efficacy and toxicity, utilizing DualityBio ADC technology.  BG-C9074 The efficacy of BG-C9074 was evaluated in a B7-H4 low/heterogeneous PDX model, as measured by tumor volume reduction. The 10 mpk dose resulted in a greater degree of tumor shrinkage compared to the 3 mpk dose. B7-H4 low/heterogeneous PDX model In addition to BG-C9074, Beigene plans to initiate another ADC targeting B7-H3 with stable DAR8 and a strong bystander effect. -------------------------

Alphamab has filed the IND application for anti-HER3xTROP2 ADC in China

 Alphamab Oncology has submitted the IND application for JSKN016, an anti-HER3xTROP2 ADC designed for the treatment of solid tumors in China. JSKN016 represents a potential first-in-class bispecific ADC, developed using the glycan-specific conjugation platform to target both HER3 and TROP2. No further details have been reported, and we will provide updates as they become available. Anti-TROP2 ADC, sacituzumab govitecan, has received approval for the treatment of breast cancer and urothelial cancer. Lung cancer may be the next targeting indication. Concurrently, anti-HER3 ADCs are widely investigated for their therapeutic potential in both lung cancer and breast cancer.